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Detecting Malingering Detection Using Eye Movements and Response Time (MDER)

L

Loewenstein Hospital

Status

Unknown

Conditions

Chronic Pain
Traumatic Brain Damage

Treatments

Behavioral: optimal effort
Behavioral: Sub-optimal effort

Study type

Interventional

Funder types

Other

Identifiers

NCT03201887
Tasmc16ys0ctil

Details and patient eligibility

About

Performance Validity Tests (PVTs) are widely used for the detection of sub-optimal effort and malingering in neuropsychological assessments. Threats to their validity however likely to intensify with time (e.g., information available on the web or from legal representatives) and may lead to a decline in their ability to differentiate between malingerers and non-malingerers. Eye movements and response time (RT) are less obvious outcome measures and under less conscious control than more conventional PVT indices (e.g., accuracy). They are therefore promising measures that can aid in detecting malingering when used in conjunction with more conventional PVT indices. The Word Memory Test (WMT) is a widely used PVT in neuropsychological evaluations. As part of the proposed study, TBI patients, chronic pain patients and healthy adults (60 in each group) will be randomly divided to one of two conditions; optimal effort or sub-optimal effort (participants will be asked to play a TBI patient who wishes to present himself as having cognitive deficits or exaggerate existing cognitive deficits). The proposed study will improve the WMT's efficacy in detection of sub-optimal effort in neuropsychological evaluations and therefore protect its validity from future threats. In addition, the proposed study will provide us with better understanding of the effect of TBI on eye movements and RTs in general.

Full description

Same as in the brief summary

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for all participants:

  • Adult (18-65) female and males.
  • Signed informed consent form.

Inclusion criteria for TBI group:

  • TBI of at least mild severity, as operationalized by Post traumatic amnesia (PTA) < 24 hours
  • Glasgow coma scale (GCS) of 13-15
  • Loss of consciousness (LOC) of 30 minutes or less.

Inclusion criteria for chronic pain patients:

• Pain without apparent biological value that has persisted beyond three months. This will be based on the participant self-report, electronic medical records and consultation with treating physician.

Exclusion Criteria:

  • Exclusion criteria for all participants:
  • Any current eye impairment (e.g., limited visual field, nystagmus, astigmatism [cylinder], strabismus or any other impairment specified by the participant), past strabismus, and refractive surgery.
  • Significant past neurological disorder/s and/or neurosurgery (special emphasis will be put on any language impairment such as aphasia).
  • Significant developmental disorders (e.g., learning disabilities such as dyslexia). (d)
  • Significant past or present psychiatric disorders (as evident, for example, in psychiatric inpatient hospitalization and past suicide attempts).
  • Exclusion according to the last three articles (a-c) will be decided by a joint consultation of the research team.
  • Exclusion criteria for TBI patients and healthy adults:
  • Any condition of chronic pain (see criteria in the inclusion for the chronic pain group).
  • Exclusion criteria for chronic pain patients and health adults:
  • Significant current neurological disorder/s (special emphasis will be put on any language impairment such as aphasia) as decided by a joint consultation of the research team.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

120 participants in 4 patient groups

Sub-optimal Traumatic Brain Injury
Experimental group
Description:
Sub-optimal effort
Treatment:
Behavioral: Sub-optimal effort
Behavioral: optimal effort
Sub-optimal effort Chronic pain
Experimental group
Description:
Sub-optimal effort
Treatment:
Behavioral: Sub-optimal effort
Behavioral: optimal effort
Traumatic Brain Injury
No Intervention group
Description:
optimal effort
Chronic pain
No Intervention group
Description:
optimal effort

Trial contacts and locations

0

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Central trial contact

Moti Ratmansky, MD; Yoram Braw, PHD

Data sourced from clinicaltrials.gov

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